CYTOFLAVIN four-component neuroprotector in tablets 50 pcs

CYTOFLAVIN® enhances the intensity of aerobic glycolysis, which leads to the activation of glucose utilization and β-oxidation of fatty acids, and also stimulates the synthesis of γ-aminobutyric acid in neurons. The drug is effective in cerebral infarction (stroke) and for the treatment of the consequences of cerebrovascular diseases (cerebral infarction, cerebral atherosclerosis). The drug is characterized by nootropic properties.

CYTOFLAVIN® increases the resistance of nerve and glial cell membranes to ischemia and improves coronary and cerebral blood flow, activates metabolic processes in the central nervous system, restores disturbed consciousness, promotes regression of neurological symptoms and improves cognitive functions of the brain. It has a quick awakening effect in case of post-narcotic depression of consciousness.

Dosage form: enteric coated tablets.

Therapeutic category: metabolic regulator.

CYTOFLAVIN® possesses anti-hypoxic activity, stimulating energy production in the cells; reduces free radical generation, and restores antioxidant enzyme activities.

The medicine improves cerebral blood flow; activates metabolic processes in central nervous system, and has positive effect on bioelectrical activity of the brain.

CYTOFLAVIN® has beneficial effect on patient’s neurologic status by reducing the manifestations of asthenia, headache, vestibulocerebellar and cochlear-vestibular syndromes. It also eliminates the distress in emotional and volitive sphere of the patient by reducing anxiety and depression; improves intellectual and mental function and quality of patient’s life.

Compound:

Composition per tablet:
Active ingredients: Succinic acid 0.300 g, Inosine 0.050 g, Nicotinamide 0.025 g, Riboflavin (riboflavin sodium phosphate) 0.005 g
Excipients: povidone K 30 - 0.00810 g, calcium stearate - 0.00390 g, hypromellose - 0.00360 g, polysorbate 80 - 0.00040 g.
Enteric coating: methacrylic acid and ethyl acrylate copolymer [1:1] - 0.02902 g, propylene glycol - 0.00291 g,
dye azorubine (carmoisine) (E 122) - 0.00007 g.

Pharmacodynamics:

Pharmacological effects are due to the complex effect of the components that make up the drug CYTOFLAVIN®.
Succinic acid is an endogenous intracellular metabolite of the Krebs cycle, which performs a universal energy-synthesizing function in the cells of the body. With the participation of the coenzyme flavin adenine dinucleotide (FAD), succinic acid mitochondrial
enzyme succinate dehydrogenase is rapidly transformed into fumaric acid and then into other metabolites of the tricarboxylic acid cycle. Stimulates aerobic glycolysis and ATP synthesis in cells. The end products of succinic acid metabolism in the Krebs cycle are carbon dioxide and water. Succinic acid improves tissue respiration by activating electron transport in mitochondria.
Riboflavin (vitamin B2) is a flavin coenzyme that activates succinate dehydrogenase and the redox reactions of the Krebs cycle.
Nicotinamide (vitamin PP) is an amide of nicotinic acid. Nicotinamide in cells through a cascade of biochemical reactions is transformed into the form of nicotinamide adenine dinucleotide (NAD) and its phosphate (NADP), activating nicotinamide-dependent Krebs cycle enzymes necessary for Inosine is a purine derivative, a precursor of ATP. It has the ability to activate a number of Krebs cycle enzymes, stimulating the synthesis of key nucleotide enzymes: flavin adenine dinucleotide (FAD) and nicotinamide adenine dinucleotide (NAD). Thus, all components of CYTOFLAVIN® are natural metabolites of the body and stimulate tissue respiration. Metabolic energy correction, antihypoxic and antioxidant activity of the drug, which determine the pharmacological properties and therapeutic efficacy of the components, are due to the complementary action of succinic acid, inosine, nicotinamide and riboflavin.

Pharmacokinetics:

CYTOFLAVIN® has a high bioavailability.
Succinic acid, when taken orally, penetrates from the gastrointestinal tract into the blood and tissues, participating in energy metabolism reactions, and completely decomposes to the final products of metabolism (carbon dioxide and water) after 30 minutes.
Inosine is well absorbed from the gastrointestinal tract. The time to reach the maximum concentration in the blood is 5 hours, the average retention time in the blood is 5.5 hours, the equilibrium volume of distribution is about 20 liters. Inosine is metabolized to
liver with the formation of inosine monophosphate, followed by its oxidation to uric acid. In a small amount excreted by the kidneys.
Nicotinamide is rapidly distributed in all tissues (equilibrium volume of distribution is about 500 liters). The time to reach the maximum concentration in the blood is 2 hours, the average retention time in the blood is 4.5 hours. Nicotinamide crosses the placenta and into breast milk; metabolized in the liver to form N-methylnicotinamide, excreted by the kidneys.
Riboflavin is rapidly absorbed from the gastrointestinal tract, distributed unevenly (the largest amount in the myocardium, liver, kidneys), transformed into flavin adenine mononucleotide (FMN) and flavin adenine dinucleotide (FAD) in mitochondria. Penetrates through the placenta and into breast milk; excreted by the kidneys, mainly in the form of metabolites.

Indications for use:

The drug CYTOFLAVIN® is used in adults over 18 years of age in complex therapy:

- consequences of cerebral infarction (stroke);
- other cerebrovascular diseases (cerebral atherosclerosis, hypertensive encephalopathy);
- neurasthenia (increased irritability, fatigue, loss of ability for prolonged mental and physical stress);
- diabetic polyneuropathy;
- for the prevention of cognitive disorders after major surgical interventions in patients over 60 years of age.

Use of Cytoflavin:

The drug CYTOFLAVIN® is taken orally 2 tablets 2 times a day with an interval of 8-10 hours. Tablets should be taken at least 30 minutes before meals with water (100 ml). It is forbidden to chew, divide, break and crush the tablets when taking. The enteric coating of the tablets allows you to localize the effect of the drug in the intestines and protect the stomach. It is recommended to take the drug in the morning and afternoon (no later than 18 hours).
In the complex therapy of the consequences of cerebral infarction, other cerebrovascular diseases, neurasthenia, the duration of treatment is 25 days. It is recommended to repeat the course with an interval of 1 month. In the complex therapy of diabetic polyneuropathy, the duration of treatment is 75 days. The use of the drug is started on the next day after the end of the course of treatment with the drug "CYTOFLAVIN® solution for intravenous administration".
In complex therapy for the prevention of cognitive disorders after major surgical interventions in elderly patients, the duration of treatment is 25 days. The use of the drug is started on the next day after the end of the course of treatment with the drug "CYTOFLAVIN® solution for intravenous administration" (144 (+4) hours after the start of the operation).

Contraindications:

Individual intolerance to the components of the drug. Not recommended for use in children under 18 due to lack of efficacy and safety data.

Carefully:

Diseases of the digestive system (erosion, gastric and / or duodenal ulcers, gastritis and duodenitis (in the acute stage)), arterial hypotension, nephrolithiasis, concomitant gout, hyperuricemia. Use CYTOFLAVIN® with caution in patients undergoing cardiac surgery using
heart-lung machine, due to the lack of clinical studies in this patient groups. If you have one of the listed diseases, be sure to consult your doctor before taking the drug.
Use during pregnancy and during breastfeeding. It is not recommended to take during pregnancy and during breastfeeding due to the lack of clinical data on the efficacy and safety of the drug during these periods.

Dosage and administration:

Tablets should be taken at least 30 minutes before meals, without chewing, with water (100 ml). It is recommended to take the drug in the morning and afternoon (no later than 18 hours). In the complex therapy of the consequences of cerebral infarction, other cerebrovascular diseases, neurasthenia, the drug is taken 2 tablets
2 times a day with an interval of 8-10 hours. The duration of the course of treatment is 25 days. Repetition of the course is possible with an interval of at least 1 month.
For the prevention of cognitive disorders after major surgical interventions in elderly patients, the drug is taken 2 tablets 2 times a day with an interval of 8-10 hours for 25 days. Start of application
CYTOFLAVIN® enteric-coated tablets is recommended 144 (± 4) hours after the start of the operation, that is, on the next day after the end of the course of treatment with CYTOFLAVIN® solution for intravenous administration.

Side effects:

According to the World Health Organization, adverse reactions are classified according to their frequency of development as follows:
- very frequent (? 1/10);
- frequent (? 1/100 - < 1/10);
- infrequent (? 1/1000 - < 1/100);
- rare (? 1/10000 - < 1/1000);
- very rare (< 1/10000);
- frequency unknown (cannot be determined on available data).
Skin and subcutaneous tissue disorders: very rarely - itching, urticaria, rash.
Vascular disorders: very rarely hyperemia.
Nervous system disorders: very rarely - headache.
From the gastrointestinal tract: very rarely - pain in the epigastric region, discomfort in the epigastric region, nausea.
Metabolic and nutritional disorders: very rarely - transient hypoglycemia, hyperuricemia, exacerbation of concomitant gout. If any of the adverse reactions indicated in the instructions are aggravated or you notice any other adverse reactions not listed in the instructions, tell your doctor about it.

Overdose:

So far, no cases of overdose with CYTOFLAVIN® have been established.

Drug interaction:

Succinic acid, inosine and nicotinamide are compatible with other drugs.
Riboflavin reduces the activity of some antibiotics (tetracyclines, erythromycin, lincomycin), is incompatible with streptomycin. Ethanol, tricyclic antidepressants, blockers of tubular secretion reduce the absorption of riboflavin, and thyroid hormones accelerate its metabolism.

Special instructions:

In hypertension, dose adjustment of antihypertensive drugs may be required.
In patients with diabetes mellitus, treatment should be carried out under the control of blood glucose concentration. Perhaps intense staining of urine in yellow.

Influence on the ability to drive vehicles, mechanisms:

CYTOFLAVIN® does not affect the ability to drive vehicles, mechanisms.

Storage temperature: 2℃ to 25℃

Form release:

enteric-coated tablets 50 pcs. Round, biconvex, red film-coated tablets. The cross section shows two layers. The core of the tablets is yellow to yellow-orange in color.

Guaranteed authenticity and quality:

100% Original from POLYSAN (Russian Federation)

POLYSAN - over 28 years of successful development. The history of POLYSAN goes back to the development of CYCLOFERON medicinal product. Now it is a holding company with its own manufacturing plants in St. Petersburg and Belgorod and is one of the leaders of the domestic pharmaceutical industry.

Advanced technologies, modern equipment and highly qualified specialists make POLYSAN STC a unique platform for the development of original innovative domestic drugs.

Drug development areas:

• cardiology;
• infectious diseases;
• geriatrics;
• oncology.

Own Scientific and Technological Center

Total area more than 4800 m2 and 3 functional units:

• laboratory;
• technological;
• stability center.

Activities of the Scientific and Technological Center:

• pharmaceutical screening;
• preclinical and clinical studies;
• introduction to production;
• pre-registration support for existing medicinal products.

Development and production:

POLYSAN (Russian Federation)